MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 18MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-018
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that patient has a history of left total knee with distal femoral replacement.Pt now complains of squeaking in the knee.The pts left knee was opened and noted to have a large amount of soft tissue in the patella femoral space.The +5 spacer was removed along with the dfr component and poly.These were revised to new components to distalize femur and adjust the external rotation of the component.Doi: (b)(6) 2018; dor: (b)(6) 2021; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Question: 1.With regards to this, please confirm if the poly patella was placed during the primary operation or during this operation.Response: primary operation.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS XXSM 18MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12369781
• Report Number: 1818910-2021-18684
• Device Sequence Number: 3924506
• Product Code: KRO
• UDI-Device Identifier: 10603295079361
• UDI-Public: 10603295079361
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1987-27-018
• Device Catalogue Number: 198727018
• Device Lot Number: 729293
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/30/2021; 09/27/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/14/2021; 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XXSM 18MM; UNKNOWN KNEE PATELLA; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XXSM 18MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR